The ASOS-2 Trial Maternal Mortality Sub-study

The African Surgical OutcomeS-2 (ASOS-2) Trial Maternal Mortality Sub-study. A Mixed-methods Analysis of a Prospective Case-series Describing Factors Contributing to Maternal Mortality Associated With Caesarean Delivery in Africa

This sub-study is a mixed-methods analysis of a prospective case-series of maternal deaths within the African Surgical OutcomeS-2 trial cohort. The aims of the sub-study are i) to describe the contextual factors that contribute towards maternal deaths after caesarean delivery in Africa using a conceptual framework of "transport-treatment-training" and ii) to classify the maternal deaths in the ASOS-2 trial according to the WHO ICD-10 maternal mortality reporting standard. Data will be extracted from the ASOS-2 trial database. A sub-study case report form (CRF) and semi-structured telephonic interviews will be used to gather additional information from clinicians who were experienced a maternal death during the trial.

Study Overview

• Status: Unknown
• Conditions: Cesarean Section; Maternal Mortality; Africa
• Intervention / Treatment: Procedure: Cesarean section

Detailed Description

This sub-study is a mixed-methods analysis of a prospective case-series of maternal deaths within the African Surgical OutcomeS-2 trial cohort. The aims of the sub-study are i) to describe the contextual factors that contribute towards maternal deaths after caesarean delivery in Africa using a conceptual framework of "transport-treatment-training" and ii) to classify the maternal deaths in the ASOS-2 trial according to the WHO ICD-10 maternal mortality reporting standard. Data will be extracted from the ASOS-2 trial database. When a maternal death is captured on the trial database, the data manager will flag the event. The hospital that registered the death will be contacted and invited to take part in the sub-study. A sub-study case report form (CRF) and semi-structured telephonic interviews will be used to gather additional information from clinicians who were experienced a maternal death during the trial.

This study uses 2 a priori frameworks for describing maternal deaths:

i) The "transport-treatment-training" framework developed by Dr Andrew Shennan (personal communication). This framework suggests that the important determinants (modifiable contextual factors) of maternal mortality can be classified as being related to transport, treatment and training factors.

• Transport refers to the manner in which the patient accesses existing care. This includes decision to seek help, modes of transportation to the hospital, and inter-facility transportation. We consider the healthcare access network in this category.
• Treatment refers to the manner in which the case was managed at the healthcare facility. It includes delays in diagnosis and decision making as well as delays between decision making and physical intervention (e.g. time from decision for caesarean delivery to time of delivery of the infant). Treatment also includes appropriateness of treatment decisions and the availability of resources needed to provide recommended treatment.
• Training refers to the availability of skilled health care providers and the need for training / upskilling of existing health care providers.

ii) The WHO application of ICD-10 codes to deaths during pregnancy, childbirth and puerperium (ICD MM) classification. Within this framework, deaths are described as having a final direct cause, an underlying cause that leads to the final cause, and contributory causes that did not directly cause death, but worsened physiological status or accelerated the underlying event.

The underlying cause of death is defined as the disease or condition that initiated the morbid chain of events leading to death or the circumstances of the accident or violence that produced a fatal injury. Underlying causes will be specified in as much detail as available. The underlying cause will be classified into one of 8 categories:

1. Hypertensive disorders in pregnancy
2. Obstetric haemorrhage
3. Pregnancy-related infection
4. Other obstetric complications
5. Unanticipated complications of management (iatrogenic)
6. Non-obstetric complications (non-obstetric disease, e.g. cardiac disease, malaria)
7. Unknown / Undetermined
8. Coincidental external causes (e.g. interpersonal violence)

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• South Africa
  • Western Cape
    • Observatory, Western Cape, South Africa, 7925
      • Groote Schuur Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

African mothers who die during or after caesarean delivery. The primary study is a cluster randomised trial which samples hospitals across Africa purposively.

Description

Inclusion Criteria:

• adult patients
• aged 18 years and over,
• admitted to participating hospitals
• undergoing elective and non-elective caesarean delivery
• who die following their operation before leaving hospital and within 30 days after the operation.

Exclusion Criteria:

• prior participation in ASOS-2
• caesarean delivery at a hospital other than the study hospital (left censored)
• patients who are transferred to another hospital before death (right censored)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

African Surgical OutcomeS-2 Trial; The ASOS-2 Trial is a cluster randomised trial purposively recruiting hospitals across Africa. To be eligible for inclusion a hospital must perform at least 20 cases of adult in-patient surgery with anaesthesia per week, have local ethics approval for the trial, have local hospital management approval and have established a local hospital study team. The trial excludes hospitals with lower surgical volume. The trial aims to include all consecutive adult in-patient surgical cases at participating hospitals (both elective and emergency surgery). Patients under the age of 18 and patients who have already been recruited into the trial are excluded from recruitment. Follow-up is in-hospital, censored at 30 days.

Procedure: Cesarean section; Abdominal, operative delivery of the fetus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transport: Mode of transport	Nominal: walking, private transport, ambulance, public transport	On the day of hospital admission
Transport: Distance	Continuous: distance in kilometers from patient's home to hospital	On the day of hospital admission
Transport: Time	Continuous: time in hours from patient's home to hospital	On the day of hospital admission
Transport: Delay in seeking healthcare	Binary: Obstetrician opinion whether there was a clinically important delay in seeking care	On the day of hospital admission
Transport: Delay in transport to healthcare	Binary: Obstetrician opinion whether there was a clinically important delay in transport	On the day of hospital admission
Transport: Inter-facility delay	Binary: Did the patient die while waiting for inter-facility transfer?	At time of death (death recorded in-hospital, censored at 30 days)
Treatment: Referral to high level of care	Binary: Whether or not referral to higher level of care took place	In-hospital censored at 30 days
Treatment: Prophylactic uterotonic use	Nominal: Oxytocin, Ergometrine, Misoprostil, Carbetocin, None	On day of caesarean section, at time of caesarean section
Treatment: Therapeutic uterotonic use	Nominal: Oxytocin, Ergometrine, Misoprostil, Carbetocin, None	On day of caesarean section, at time of caesarean section
Treatment: Surgical safety checklist	Binary: Whether or not a surgical safety checklist was used	On day of caesarean section, at time of caesarean section
Treatment: Type of anaesthetic	Nominal: Regional, general with endotracheal intubation, general without endotracheal intubation.	On day of caesarean section, at time of caesarean section
Treatment: Airway aspiration	Binary: Whether or not airway aspiration occurred	On day of caesarean section, at time of caesarean section
Treatment: Desaturation	Binary: Whether or not desaturation below 90% occurred during management of the airway	On day of caesarean section, at time of caesarean section
Treatment: Spinal hypotension	Binary: Whether or not spinal hypotension occured; systolic BP <= 90mmHg	On day of caesarean section, at time of caesarean section
Treatment: Interventions to arrest bleeding	Nominal: Which techniques were used? over-sowing, uterine compression suture, uterine artery ligation, uterine tourniquet, intrauterine balloon, hysterectomy, uterine artery embolisation	In hospital, censored at 30 days
Treatment: Blood products	Nominal: Which products were given? Red blood cells, fresh frozen plasma, freeze dried plasma, cryoprecipitate, platelets, whole blood.	In hospital, censored at 30 days
Treatment: Availability of medications	Nominal: Oxygen, Propofol, Thiopentone, Etomidate, Ketamine, Suxamethonium, Rocuronium, Nitrous Oxide, Halothane, Isoflurane, Sevoflurane, Oxytocin, Ergometrine, Syntometrine, Misoprostil, Prostaglandin F2alpha, Carbetocin, Phenylephrine, Ephedrine, Adrenalin, Noradrenalin, Morphine, Fentanyl, Pethidine, Lignocaine, Bupivacaine, Tranexamic Acid	On day of caesarean section
Treatment: Availability of blood products	Nominal: Red blood cells, Plasma, Platelets, Cryoprecipitate	On day of caesarean section
Treatment: Availability of resuscitation equipment	Nominal: Airway suction, endotracheal intubation equipment, mechanical ventilator, supraglottic airway devices, defibrillator,	On day of caesarean section
Treatment: Availability of monitoring equipment	Nominal: Which monitoring equipment are available in the recovery area and the postoperative ward? O2 saturation, blood pressure, heart rate monitor, thermometer	On day of caesarean section
Treatment: Recovery area	Binary: Is there a dedicated area where the patient is monitored during recovery from anaesthesia for caesarean section?	On day of caesarean section
Treatment: Provider-patient ratio	Interval: Nurse-to-patient ratio in postoperative ward (during the day, during the night)	On day of caesarean section
Treatment: Delay in diagnosis	Binary: Obstetrician opinion whether a clinical important delay in diagnosis occurred	On day of caesarean section
Treatment: Delay between diagnosis and caesarean section	Binary: Obstetrician opinion whether a clinical important delay between diagnosis and caesarean section occurred	On day of caesarean section
Treatment: Access to hospital resources	Nominal: Obstetrician opinion whether delayed access or lack of hospital resources contributed to the death: water supply, electricity, medications, telephone, anaesthetic equipment, surgical equipment, monitoring equipment, operating theatre, nursing or assistant, on-call senior obstetric doctor, on-call senior anaesthetic doctor, advice from referral center.	On day of caesarean section
Training: Level of training	Nominal: Provider level of training at caesarean seciton (for anaesthesia and surgery): Specialist, specialist trainee, non-specialist doctor, non-doctor	At time of caesarean section

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cause of death	WHO ICD-10 maternal mortality reporting standard	Maternal death is recorded in-hospital, censored at 30 days.

Collaborators and Investigators

• Sponsor: University of Cape Town
• Collaborators: Bill and Melinda Gates Foundation
• Investigators: Principal Investigator: Professor Bruce M Biccard, University of Cape Town

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2019
• Primary Completion (Anticipated): July 31, 2020
• Study Completion (Anticipated): July 31, 2020

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Parental Death; Maternal Death
• Other Study ID Numbers: ASOS-2 Maternal Mortality

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The Principle Investigator will receive requests to share individual participant data and will decide on a case by case basis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No